Course Overview

Internal auditing is fundamental to any improvement initiative. The GDPMD standard requires an organisation to conduct internal audits to determine the effectiveness of its Good Distribution Practice for Medical Devices system, and only trained internal auditors can carry out these audits.

This GDPMD training equips participants with the knowledge and skills needed to assess and report on the conformance and effective implementation of processes, and to contribute to the continual improvement of the management system. Through practical workshops, case studies and role-play, delegates gain the skills to plan, conduct and report audit findings, including follow-up audits on corrective actions taken to ensure continual improvement.

Good Distribution Practice of Medical Device training applies GDPMD requirements across storage, handling, transport, traceability, complaints and recalls, supporting the establishment-licensing requirements assessed by the Medical Device Authority. Establishments that also hold ISO 13485 for medical devices in Malaysia can align distribution controls with the wider quality management system so traceability and corrective-action records stay consistent.

Objective:

The programme aims to provide delegates with the knowledge and ability to:

  • Understand and get involved in the audit process
  • Improve audit efficiency and effectiveness
  • Understand objectivity and consistency in the internal audit process
  • Use auditing as a tool to monitor the performance of the company's Good Distribution Practice for Medical Devices Training

Target Participants

This training is targeted for companies who intend to attain GDPMD certification, or participants who want to acquire knowledge in relation to the GDPMD requirements and application.

A group of a maximum of 20 participants is recommended to ensure the effectiveness of the training.

Typical attendees include appointed internal auditors, regulatory affairs and quality assurance officers, warehouse and logistics supervisors, and establishment licence holders or their nominated persons responsible.

Agenda:

This one-day GDPMD training agenda covers GDPMD requirements and how they map to establishment licensing, audit planning and checklist preparation, the audit process from opening meeting to closing meeting, and audit reporting with corrective-action follow-up. Eligible programmes may be claimable under HRD Corp's SBL Khas scheme, subject to employer eligibility and programme approval.

 

    • 9am

      • Section 1 – Introduction to Auditing
      • Section 2 – GDPMD Requirements
        • General requirements
      • Section 3 – Audit Planning
        • Establish audit plan
        • Workshop

    • 1pm – 2pm

      • Lunch

    • 2pm

      • Section 4 – Audit Checklists
        • Establish audit checklist based on GDPMD requirements
        • Workshop
      • Section 5 – Audit Process
        • Opening Meeting
        • Audit Method
        • Audit reporting
        • Closing Meeting
      • Section 6 – Audit Reporting and Follow-up

    • 5pm

      • End of course

        Certificate of Attendance will be awarded upon completion of course.

         

Training Methodology:

  • Classroom lecture, brainstorming, exercises, questions and answers

Establishments that also run Good Manufacturing Practice (GMP) or HACCP training can align their Good Distribution Practice of Medical Device training internal-audit cycle with these existing programmes, coordinating audit schedules and corrective-action follow-up across systems.

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Frequently Asked Questions About Good Distribution Practice of Medical Device Training

Answers to common questions about establishment licensing, course duration, internal-auditor coverage, ISO 13485 and HRD Corp eligibility.

What Is GDPMD Training?
GDPMD training explains the Malaysian quality-management requirements governing medical-device sourcing, storage, transportation, installation, servicing, traceability, complaints and post-market activities.
Who Needs GDPMD Certification in Malaysia?
Authorised representatives, importers and distributors generally need a GDPMD-based QMS as part of their establishment licensing requirements. Manufacturers are normally assessed against ISO 13485 requirements for their manufacturing QMS.
What Is the Difference Between GDPMD Training and Certification?
Good Distribution Practice of Medical Device training develops staff knowledge and implementation competence. Certification involves an independent conformity assessment of the establishment’s actual QMS and distribution activities.
What Is the Difference Between ISO 13485 and GDPMD?
ISO 13485 certification in Malaysia focuses mainly on medical-device manufacturing and related lifecycle controls. GDPMD focuses on post-manufacturing supply-chain activities performed by authorised representatives, importers and distributors.
What Topics Are Covered in GDPMD Training?
Training may cover regulatory responsibilities, supplier controls, storage conditions, transport, traceability, installation, servicing, calibration, complaints, recalls, adverse-event reporting, internal audits and document control.
How Long Does GDPMD Implementation Take?
The timeframe depends on the establishment’s activities, number of locations, warehousing arrangements, current procedures and available compliance records. A gap assessment should be completed before setting the certification schedule.
Can a Company Use a Third-Party Warehouse Under GDPMD?
A company may use an outsourced warehouse or logistics provider, but the arrangement must be controlled through documented responsibilities, supplier evaluation and suitable storage and traceability requirements. The establishment should also confirm the applicable MDA and conformity-assessment requirements.
How Can One Island Support GDPMD Certification?
One Island can provide GDPMD training, gap assessment, QMS documentation, internal audit preparation and certification-readiness support. Guidance can be adjusted for authorised representatives, importers, distributors and organisations using outsourced logistics providers. Contact One Island to review the establishment role and logistics scope.

Enquire About GDPMD Training in Malaysia

Share your establishment activities, licence scope, distribution controls and current internal-audit programme. The course can then be matched to the responsibilities of your auditors and quality team.

Contact One Island